MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH SYNGO.PLAZA; PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM

Model Number 10863172

Device Problem Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/06/2020

Event Type  malfunction  

Manufacturer Narrative

The syngo.Plaza works according to specifications.The reported issue at the concerned site is caused by outdated bsod - microsoft software.No consequences have been reported, neither from this customer nor from the installed base.Internal id #(b)(4).

Event Description

Siemens became aware of an incident on the syngo.Plaza unit.The application log files showed multiple instances of abnormal shutdown (power outage or windows blue screen/bsod issues) of the machine.Due to this interruption in file transfer process, the image files were not successfully stored to the local file system, resulting in archive failure and loss of physical files.Total # of images lost - 2067.Total # of studies lost- 52.Total # of series affected - 73.Affected studies are dated 2014, 2015, 2016, 2017, 2018 and 2019.Loading, archiving and auto-routing of such images will fail as some of the images are corrupted and unreadable.Prior images are no available for comparison either.There was no injury associated with the issue.The reported event occurred in (b)(6).

• Brand Name: SYNGO.PLAZA
• Type of Device: PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; henkesstrasse 127; forchheim, 91052 ; GM 91052
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; henkesstrasse 127; forchheim, 91052 ; GM 91052
• Manufacturer Contact: anastasia sokolova ; 40 liberty blvd.; mc 65-1a; malvern, PA 19355 ; 6104486478
• MDR Report Key: 9621665
• MDR Text Key: 221293735
• Report Number: 3002808157-2020-14363
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: K132532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 10863172
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/07/2020
• Initial Date FDA Received: 01/23/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other